RegWardenFDA facility compliance records
Recall

Class II — bioMerieux, Inc.

Recalling firmBIOMERIEUX SA
Registered facilityView this company's 16 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusOngoing
ReasonThere is a potential of no result leading to possible delayed result due to contamination of extraction reagents.
ProductNUCLISENS easyMAG Magnetic Silica, REF 280133, 24 x 1.2mL bottles/kit.
Quantity1,301 kits
DistributionDistribution was made to AR, AZ, CA, CT, FL, IL, IN, KS, KY, MA, MD, MI, MN, MO, MT, NC, NJ, NY, OH, OR, PA, TN, TX, and VA. There was no government/military distribution.
Initiated2022-07-20
Classified2022-08-23
Recall numberZ-1564-2022
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — bioMerieux, Inc. (Z-1564-2022).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90596/

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